GARDEN GROVE, Calif.—Kadesh Inc. announced last week that it is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle. (The code is UPC 7 36972 1679 0.) During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility, the company said in its announcement. This product is an over-the-counter homeopathic eye drop that is used for the temporary relief of burning and irritation due to dryness of the eye and discomfort due to minor irritations of the eye or to exposure to wind or sun, the company said.

It is packaged in a 15-ml plastic bottle. The product was distributed nationwide via the company’s own online stores and retail distributors. Use of a non-sterile eye drop is potentially vision-threatening due to the risk of an eye infection. As of last week, Kadesh said it has not received any reports of adverse events related to this recall.

Consumers and businesses that have the product are recommended to stop using and selling, the announcement noted. To have questions regarding this recall answered, contact the company’s recall department at contact@puriton.us Monday through Friday, from 9 a.m. to 6 p.m. (Pacific Time).